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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00801086
Other study ID # MITO 02-03
Secondary ID
Status Recruiting
Phase Phase 2
First received December 1, 2008
Last updated December 2, 2008
Start date November 2008
Est. completion date June 2010

Study information

Verified date December 2008
Source Mitos Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date June 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended.

- Hair that covers the scalp and is at least 1/4 inch in length

Exclusion Criteria:

- Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.

- Pre-existing alopecia

- Previous brain radiotherapy

- scalp metastases or scalp wounds

- use of hair dyes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
7% (w/v) Tempol alcohol-based gel (MTS-01)
200mL gel applied daily prior to radiation dose and removed immediately thereafter.
alcohol-based gel
200mL gel applied daily prior to radiation dose and removed immediately thereafter

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania
United States University of Arizona Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Mitos Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo. Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment. No
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